German medical device company Siemens Healthineers' CLINITEST Rapid COVID-19 Antigen Self-Test has been granted an Emergency Use Authorization (EUA) from the FDA. As testing needs mount, this easy-to-use, 15-minute nasal swab kit for at-home testing will provide the market with a much-needed additional option. Hoping to quickly proliferate its new product, Siemens has managed to secure dedicated production capacity for U.S.-bound tests and will manufacture them at a rate of tens of millions per month.
Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers, said, “The CLINITEST Rapid COVID-19 Antigen Self-Test detects SARS-CoV-2 antigens in people who are actively infected with the virus, making important information more readily available. We’d like to thank the U.S. Government, specifically the National Institutes of Health Rapid Acceleration of Diagnostics’ Independent Test Assessment Program, for their partnership in bringing much needed tests to the American people. We know this is a critical time in this pandemic, and we will do our part in providing support.”
The EUA for unsupervised self-testing extends to individuals of age 14 and older, and adult-collected samples from individuals ages two to 13 are also covered. The CLINITEST met the FDA's high threshold for test accuracy; its sensitivity (ability to detect a positive result) hit 86.5% and its specificity (ability to detect a negative result) reached 99.3%. Clinical data was derived from Siemens' participation in the National Institutes of Health Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP).
